EP1404303A4 - Stable pharmaceutical compositions containing pravastatin - Google Patents

Stable pharmaceutical compositions containing pravastatin

Info

Publication number
EP1404303A4
EP1404303A4 EP02741842A EP02741842A EP1404303A4 EP 1404303 A4 EP1404303 A4 EP 1404303A4 EP 02741842 A EP02741842 A EP 02741842A EP 02741842 A EP02741842 A EP 02741842A EP 1404303 A4 EP1404303 A4 EP 1404303A4
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical compositions
compositions containing
stable pharmaceutical
containing pravastatin
pravastatin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP02741842A
Other languages
German (de)
French (fr)
Other versions
EP1404303A1 (en
Inventor
Boyong Li
Avinash Nangia
Aaron Dely
David Wong
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Andrx Pharmaceuticals LLC
Original Assignee
Andrx Pharmaceuticals LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Andrx Pharmaceuticals LLC filed Critical Andrx Pharmaceuticals LLC
Publication of EP1404303A1 publication Critical patent/EP1404303A1/en
Publication of EP1404303A4 publication Critical patent/EP1404303A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP02741842A 2001-06-21 2002-06-05 Stable pharmaceutical compositions containing pravastatin Withdrawn EP1404303A4 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US30002701P 2001-06-21 2001-06-21
US300027P 2001-06-21
PCT/US2002/017713 WO2003000239A1 (en) 2001-06-21 2002-06-05 Stable pharmaceutical compositions containing pravastatin

Publications (2)

Publication Number Publication Date
EP1404303A1 EP1404303A1 (en) 2004-04-07
EP1404303A4 true EP1404303A4 (en) 2006-03-15

Family

ID=23157356

Family Applications (2)

Application Number Title Priority Date Filing Date
EP02741842A Withdrawn EP1404303A4 (en) 2001-06-21 2002-06-05 Stable pharmaceutical compositions containing pravastatin
EP02739658A Withdrawn EP1404301A4 (en) 2001-06-21 2002-06-05 Stable controlled release pharmaceutical compositions containing pravastatin

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP02739658A Withdrawn EP1404301A4 (en) 2001-06-21 2002-06-05 Stable controlled release pharmaceutical compositions containing pravastatin

Country Status (5)

Country Link
US (2) US7642286B2 (en)
EP (2) EP1404303A4 (en)
JP (2) JP2005500307A (en)
CA (2) CA2449998A1 (en)
WO (2) WO2003000177A2 (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005500307A (en) * 2001-06-21 2005-01-06 アンドルックス ファーマスーティカルズ インコーポレーテッド Stable sustained release pharmaceutical composition comprising pravastatin
JP2003055217A (en) * 2001-08-10 2003-02-26 Taiyo Yakuhin Kogyo Kk Pharmaceutical composition
SI21402A (en) * 2003-02-12 2004-08-31 LEK farmacevtska dru�ba d.d. Lined particles and pharmaceutical forms
US8163797B2 (en) * 2003-12-31 2012-04-24 Actavis Elizabeth Llc Method of treating with stable pravastatin formulation
WO2006008757A2 (en) * 2004-05-05 2006-01-26 Cadila Healthcare Limited Stabilized pharmaceutical compositions of pravastatin
WO2006006021A2 (en) * 2004-06-28 2006-01-19 Glenmark Pharmaceuticals Limited Stabilized pharmaceutical compositions of preferably a statin
AU2005271413A1 (en) 2004-08-06 2006-02-16 Transform Pharmaceuticals, Inc. Novel statin pharmaceutical compositions and related methods of treatment
US10475700B2 (en) * 2017-08-31 2019-11-12 Taiwan Semiconductor Manufacturing Company, Ltd. Etching to reduce line wiggling
MX2021010066A (en) 2019-02-20 2021-09-21 Zoetis Services Llc Palatable formulations.

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5356896A (en) * 1991-12-12 1994-10-18 Sandoz Ltd. Stabilized pharmaceutical compositions comprising an HMG-CoA reductase inhibitor compound
WO2000035425A1 (en) * 1998-12-16 2000-06-22 Lek Pharmaceutical And Chemical Company D.D. STABLE PHARMACEUTICAL FORMULATION COMPRISING A HMG-CoA REDUCTASE INHIBITOR
WO2001093860A1 (en) * 2000-06-09 2001-12-13 Lek Pharmaceuticals D.D. Stabilized pharmaceutically effective composition and pharmaceutical formulation comprising the same
WO2002089788A2 (en) * 2001-05-04 2002-11-14 Sandoz Gmbh Pharmaceutical compositions comprising a hmg-coa reductase inhibitor

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5612114B2 (en) 1974-06-07 1981-03-18
US4137322A (en) 1976-11-02 1979-01-30 Sankyo Company Limited ML-236B carboxylic acid derivatives and their use as antihyperlipemic agents
DK149080C (en) 1980-06-06 1986-07-28 Sankyo Co METHOD FOR PREPARING ML-236B CARBOXYLIC ACID DERIVATIVES
US4976967A (en) * 1987-08-03 1990-12-11 Merck & Co., Inc. Resin modulated drug delivery device for the delivery of HMG-CoA reductase inhibitor salts
CA1331563C (en) * 1987-08-03 1994-08-23 Gaylen M. Zentner Device for the controlled release of drugs with donnan-like modulation by charged insoluble resins
US5180589A (en) 1988-03-31 1993-01-19 E. R. Squibb & Sons, Inc. Pravastatin pharmaceuatical compositions having good stability
US5030447A (en) 1988-03-31 1991-07-09 E. R. Squibb & Sons, Inc. Pharmaceutical compositions having good stability
US4997658A (en) * 1988-11-21 1991-03-05 Merck & Co., Inc. Method for enhancing the lowering of plasma cholesterol levels
US5260305A (en) 1988-12-12 1993-11-09 E. R. Squibb & Sons, Inc. Combination of pravastatin and nicotinic acid or related acid and method for lowering serum cholesterol using such combination
US5157025A (en) * 1991-04-01 1992-10-20 E. R. Squibb & Sons, Inc. Method for lowering serum cholesterol employing a phosphorus containing ace inhibitor alone or in combination with a cholesterol lowering drug
US5225202A (en) * 1991-09-30 1993-07-06 E. R. Squibb & Sons, Inc. Enteric coated pharmaceutical compositions
SE9500478D0 (en) 1995-02-09 1995-02-09 Astra Ab New pharmaceutical formulation and process
ZA97976B (en) * 1996-04-05 1997-08-18 Alza Corp Uniform drug delivery theraphy.
US6673831B1 (en) 1996-04-17 2004-01-06 Merck & Co., Inc. Combination therapy for reducing the risks associated with cardiovascular disease
US6235311B1 (en) * 1998-03-18 2001-05-22 Bristol-Myers Squibb Company Pharmaceutical composition containing a combination of a statin and aspirin and method
SI20070A (en) 1998-09-18 2000-04-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. NOVEL SALTS OF INHIBITORS OF HMG-CoA REDUCTASE
WO2000033821A1 (en) * 1998-12-07 2000-06-15 Bristol-Myers Squibb Company Enteric coated pravastatin bead formulation
AU2001253287B2 (en) 2000-04-10 2005-04-28 Teva Pharmaceutical Industries Ltd. Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids
US6806290B2 (en) 2000-06-09 2004-10-19 Lek Pharmaceuticals D.D. Stabilized pharmaceutically effective composition and pharmaceutical formulation comprising the same
US20020055533A1 (en) 2000-09-01 2002-05-09 Sankyo Company, Limited Pharmaceutical composition
JP2002121172A (en) 2000-10-16 2002-04-23 Sankyo Co Ltd Method for purifying pravastatin or pharmacologically acceptable salt thereof
JP2005500307A (en) * 2001-06-21 2005-01-06 アンドルックス ファーマスーティカルズ インコーポレーテッド Stable sustained release pharmaceutical composition comprising pravastatin
CA2464531A1 (en) 2001-11-05 2003-05-15 Brigham And Women's Hospital, Inc. Soluble cd40l(cd154) as a prognostic marker of atherosclerotic diseases
US7611728B2 (en) 2003-09-05 2009-11-03 Supernus Pharmaceuticals, Inc. Osmotic delivery of therapeutic compounds by solubility enhancement

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5356896A (en) * 1991-12-12 1994-10-18 Sandoz Ltd. Stabilized pharmaceutical compositions comprising an HMG-CoA reductase inhibitor compound
WO2000035425A1 (en) * 1998-12-16 2000-06-22 Lek Pharmaceutical And Chemical Company D.D. STABLE PHARMACEUTICAL FORMULATION COMPRISING A HMG-CoA REDUCTASE INHIBITOR
WO2001093860A1 (en) * 2000-06-09 2001-12-13 Lek Pharmaceuticals D.D. Stabilized pharmaceutically effective composition and pharmaceutical formulation comprising the same
WO2002089788A2 (en) * 2001-05-04 2002-11-14 Sandoz Gmbh Pharmaceutical compositions comprising a hmg-coa reductase inhibitor

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO03000239A1 *

Also Published As

Publication number Publication date
JP2005500307A (en) 2005-01-06
US20050165091A1 (en) 2005-07-28
CA2450001A1 (en) 2003-01-03
CA2449998A1 (en) 2003-01-03
WO2003000239A1 (en) 2003-01-03
WO2003000177A2 (en) 2003-01-03
JP2004536826A (en) 2004-12-09
EP1404303A1 (en) 2004-04-07
US20090292016A1 (en) 2009-11-26
EP1404301A2 (en) 2004-04-07
US7642286B2 (en) 2010-01-05
EP1404301A4 (en) 2006-03-22
WO2003000177A3 (en) 2003-11-06

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Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20031219

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE TR

AX Request for extension of the european patent

Extension state: AL LT LV MK RO SI

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: ANDRX PHARMACEUTICALS, INC.

RIN1 Information on inventor provided before grant (corrected)

Inventor name: WONG, DAVID

Inventor name: DELY, AARON

Inventor name: NANGIA, AVINASH

Inventor name: LI, BOYONG

A4 Supplementary search report drawn up and despatched

Effective date: 20060201

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20051231